Musculoskeletal PainNCT04261647
Kinesio-taping Versus Pelvic Floor Exercise for Post Colonoscopy Coccydynia
A study testing kinesio-taping techniques., Pelvic floor exercise and traditional physical therapy program , stretching of piriformis. iliopsoas, clam shell exercise,seat cushioning and seat kitz. in people with Musculoskeletal Pain, run by Hadaya Mosaad.
Trial summary
Forty-two patients, with coccydynia following colonoscopy were selected from Kasr El-Aini teaching Hospital, with age ranged from 25-45 years. Patients were randomly assigned to the control or experimental groups. Read more about this study
- Who is it for?
- Ages 25 to 45 years
- Conditions the study is for
- Musculoskeletal Pain
- What is being tested?
- kinesio-taping techniques., Pelvic floor exercise and traditional physical therapy program , stretching of piriformis. iliopsoas, clam shell exercise,seat cushioning and seat kitz.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 30 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients suffering from pain in or around the coccyx, following colonoscopy procedures.
- Age group ranging from 38-58 years old.
Who cannot join
- Cancer.
- , - Cysts in pelvic area.
- Pelvic fracture or recent trauma.
- Patient with pain in coccyx region referred from lumbar spine, pelvic floor muscles, degenerative disc, neoplasms, bony spurs, or infections.
About this study
Official title: The Effect of Adding Kinesio-taping Versus Pelvic Floor Exercise to Conventional Therapy in the Management of Post-colonoscopy Coccydynia
Forty-two patients, with coccydynia following colonoscopy were selected from Kasr El-Aini teaching Hospital, with age ranged from 25-45 years. Patients were randomly assigned to the control or experimental groups. The patients in the three groups completed 3-weeks 3 sessions per week for traditional physical therapy treatment consisting of stretching exercise for the piriformis and iliopsoas muscles, clamshell exercise, seat cushioning and seat kitz. Experimental group I received kinsiotaping techniques in addition to the traditional physical therapy. While experimental group II received pelvic floor exercise in the form of reverse kegel exercise or pelvic pulges, in addition to conventional therapies. pain intensity were evaluated by numerical rating scale as a primary out come measure, and Oswestry disability index was used as a secondary out come measure.
- Conditions
- Musculoskeletal Pain
- Being tested
- kinesio-taping techniques., Pelvic floor exercise, traditional physical therapy program , stretching of piriformis. iliopsoas, clam shell exercise,seat cushioning and seat kitz.
- Keywords
- pelvic floor exercise, coccydynia
- Medical subject headings
- Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kinesio-taping techniques.Other
Pelvic floor exerciseOther
traditional physical therapy program , stretching of piriformis. iliopsoas, clam shell exercise,seat cushioning and seat kitz.Other
| Study group | Role | What they receive |
|---|---|---|
| Experimental group 1 | Experimental | kinesio- taping technique plus traditional physical therapy program. Receives: Other: kinesio-taping techniques.; Other: traditional physical therapy program , stretching of piriformis. iliopsoas, clam shell exercise,seat cushioning and seat kitz. |
| Experimental group 2 | Experimental | Pelvic floor exercise plus traditional physical therapy program. Receives: Other: Pelvic floor exercise; Other: traditional physical therapy program , stretching of piriformis. iliopsoas, clam shell exercise,seat cushioning and seat kitz. |
| Control group | Active comparator | traditional physical therapy program in the form of stretching of piriformis, stretching of iliopsoas and clam shell exercise, seat cushioning and seat kitz. Receives: Other: traditional physical therapy program , stretching of piriformis. iliopsoas, clam shell exercise,seat cushioning and seat kitz. |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain intensity measured by numerical rating scale.
a one-dimensional measure of pain intensity in adults, including those with chronic pain. Numerical pain rating scale consists an 11-point numeric scale with 0 representing "no pain" and 10 representing extreme pain (Worst possible pain)
Measured: after 3 weeks of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start1 Jan 2017
- Primary completion30 Dec 2017
- Study completion30 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadaya Mosaad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hadaya Mosaad, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04261647
- Sponsor's protocol ID
- P.T.REC/012002613
- Status last verified
- Feb 2020
- First submitted
- 6 Feb 2020
- Last updated
- 11 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol statistical analusis.
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Adding Kinesio-taping Versus Pelvic Floor Exercise to Conventional Therapy in the Management of Post-colonoscopy Coccydynia
- ClinicalTrials.gov ID
- NCT04261647
- Acronym / sponsor ID
- P.T.REC/012002613
- Conditions
- Musculoskeletal Pain
- Keywords
- pelvic floor exercise, coccydynia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Hadaya MosaadUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Dec 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 10 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Forty-two patients, with coccydynia following colonoscopy were selected from Kasr El-Aini teaching Hospital, with age ranged from 25-45 years. Patients were randomly assigned to the control or experimental groups. The patients in the three groups completed 3-weeks 3 sessions per week for traditional physical therapy treatment consisting of stretching exercise for the piriformis and iliopsoas muscles, clamshell exercise, seat cushioning and seat kitz. Experimental group I received kinsiotaping techniques in addition to the traditional physical therapy. While experimental group II received pelvic floor exercise in the form of reverse kegel exercise or pelvic pulges, in addition to conventional therapies. pain intensity were evaluated by numerical rating scale as a primary out come measure, and Oswestry disability index was used as a secondary out come measure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental group 1 | Experimental | Other: kinesio-taping techniques., Other: traditional physical therapy program , stretching of piriformis. iliopsoas, clam shell exercise,seat cushioning and seat kitz.kinesio- taping technique plus traditional physical therapy program. |
| Experimental group 2 | Experimental | Other: Pelvic floor exercise, Other: traditional physical therapy program , stretching of piriformis. iliopsoas, clam shell exercise,seat cushioning and seat kitz.Pelvic floor exercise plus traditional physical therapy program. |
| Control group | Active comparator | Other: traditional physical therapy program , stretching of piriformis. iliopsoas, clam shell exercise,seat cushioning and seat kitz.traditional physical therapy program in the form of stretching of piriformis, stretching of iliopsoas and clam shell exercise, seat cushioning and seat kitz. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients suffering from pain in or around the coccyx, following colonoscopy procedures.
- Age group ranging from 38-58 years old.
Key exclusion criteria (4 listed)
- Cancer.
- , - Cysts in pelvic area.
- Pelvic fracture or recent trauma.
- Patient with pain in coccyx region referred from lumbar spine, pelvic floor muscles, degenerative disc, neoplasms, bony spurs, or infections.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| kinesio-taping techniques. | Other | Experimental group 1 |
| Pelvic floor exercise | Other | Experimental group 2 |
| traditional physical therapy program , stretching of piriformis. iliopsoas, clam shell exercise,seat cushioning and seat kitz. | Other | Control group, Experimental group 1, Experimental group 2 |
Primary outcome
pain intensity measured by numerical rating scale.
Time frame: after 3 weeks of intervention.
a one-dimensional measure of pain intensity in adults, including those with chronic pain. Numerical pain rating scale consists an 11-point numeric scale with 0 representing "no pain" and 10 representing extreme pain (Worst possible pain)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Individual participant dataSharing planned: Yes. Study protocol statistical analusis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing kinesio-taping techniques., Pelvic floor exercise and traditional physical therapy program , stretching of piriformis. iliopsoas, clam shell exercise,seat cushioning and seat kitz. in people with Musculoskeletal Pain, run by Hadaya Mosaad.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain intensity measured by numerical rating scale. (time frame: after 3 weeks of intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2020.